“2010 is a breakthrough point for the domestic CRO industry.” Recalling the choice of 9 years ago, Wang Jinhai felt very fortunate. From the introduction of the new regulations in 2007, until 2010, the clinical approvals just passed. 3 years validity. This means that clinical trials starting in 2010 are carried out under stricter and more stringent requirements under the new regulations. It is in this context that in November 2010, Wang Jinhai and five founding shareholders founded Saidesheng in Beijing.
Prior to this, Wang Jinhai, who was born in clinical medicine, worked in pharmaceutical companies and CRO companies and served as a manager of clinical research departments. Marveling at the rapid development of domestic CRO enterprises, Wang Jinhai also found defects in the development of the industry. CRO enterprises are more barbaric, and the industry lacks innovative and system-constructed companies.
At that time, following the promulgation of the new Drug Registration Management Measures by the former State Food and Drug Administration in 2007, the Ministry of Health issued the “Good Manufacturing Practices for Pharmaceutical Production (Revised in 2010)” in October 2010. “At that time, I felt that this is an opportunity, and the entire CRO market will enter a more standardized and orderly growth environment.” Wang Jinhai said.
The first domestic partner to jointly start a CRO company
At the beginning of its establishment,Ctsmed provided clinical trial registration and research services for Class III drugs. In 2013, the subsidiary Dinghui Sitron was established, and Dinghui Sitron focused on providing third-party clinical trial quality management services for pharmaceutical product research and development. In 2014, the company was recognized by the national high-tech enterprise and listed on the New Third Board with sales of over 100 million. In 2015, the company’s CRO business grew further and completed the A round of financing. Since its establishment five years ago, the company’s performance has grown at an annual rate of nearly 100%.
As the volume of business increases year by year, the difficulty of clinical trial management is gradually increasing. However, under the traditional clinical trial management mode, the information transmission between the sponsors, researchers (including institutional managers), CRO companies and regulatory authorities of clinical trials is not timely, all links are information islands, management of clinical trials. All can only be supervised afterwards, and problems cannot be discovered in time. “In 2014, mobile Internet technology was rapidly applied in all walks of life. We decided to independently develop WeTrial, a clinical trial intelligent integrated cloud platform. This is the first clinical trial management system designed entirely based on the cloud platform technology concept in China and the world. Wang Jinhai said that WeTrial aims to break the information islands of clinical trial-related organizations, improve the efficiency of clinical trial management, and better ensure the quality of clinical trials.
In 2017, Sidewin’s WeTrial system was completed and fully operational, and the subsidiary Hunan Micro Test Cloud was established tio focus on clinical research informationization. “WeTrial can significantly improve the quality and efficiency of clinical trial projects, laying the foundation for the company’s business transformation.” Wang Jinhai believes that following the reform of the national drug registration classification, the original three new drugs (which have not been listed in the mainland) The drug is classified as a new class 3 generic drug (similar to the unpublished original drug in the country). Under the policy guidance, the domestic innovative drug declaration in 2017 ushered in a blowout, and the CRO industry driven by drug research and development also ushered in a broad market prospect.
With the favorable policies and broad market, the establishment of WeTrial is undoubtedly the icing on the cake. In August 2017, Sidewin completed the B round of financing. Since 2017,Ctsmed has been undertaking clinical projects for innovative medicine. In the next two or three years, the company has gradually formed a clinical trial service for innovative medicines, high-end generic clinical trial services, and integrated clinical information management. The program, as well as the four major businesses of clinical research independent third-party auditing and quality management. At present, the company has undertaken nearly 10 innovative drug projects.
For the company’s steady development, Wang Jinhai told the arterial network reporter that it depends largely on the company’s core team structure. “We are the first CRO company in China to jointly start a business.” From the very beginning to the present, the company’s founding shareholders and core team have been relatively stable. Founder and Chairman Wang Jinhai has extensive clinical research experience in the fields of anti-tumor, nervous system and cardiovascular diseases. At the same time, he is also the long-term director of the drug clinical trial website and the executive director of the Zhongguancun Qitai Drug Clinical Trial Technology Innovation Alliance. Liu Chaoyi, the company’s chief scientific officer, has more than 20 years of experience in clinical strategy planning for anti-tumor and bio-innovative drugs, and successfully completed multi-point clinical pre-clinical development and clinical new drug research projects. The company’s chief operating officer, Xu Yuyi, has over 15 years of experience in corporate management, organizational development and human resource management.
In addition, the other core members of the company are also responsible for their core business modules. “We also actively and openly introduce outstanding professionals.” Wang Jinhai said.
WeTrial – Digital Clinical Trial Solutions
“The WeTrial platform is based on cloud architecture design, with project execution and management as the core. This is a completely different product form from the traditional organization-managed software information system. The management system covers the whole life cycle of clinical trials.” Wang Jinhai explained that WeTrial It is a clinical trial intelligent integrated cloud platform independently developed byCtsmed, which integrates PV (Pharmaceutical Alert), CTMS+eTMF (Clinical Research Project Management + Document Management), SIS+ECS (Clinical Laboratory Management + Ethics Management), EDC+ IWRS (Electronic Data Acquisition + Central Stochastic System) and eCTD (Electronic General Technical Documentation) are integrated clinical trial management solutions.
Clinical trial management often involves multiple parties. The sources of data, long test period, low information sharing rate and low efficiency of cross-organizational tasks are important reasons for high cost of clinical trials, uncontrollable quality and low efficiency.
By bringing together multiple systems, the WeTrial platform is the link between the sponsor, CRO, clinical trials and regulatory authorities. Based on the cloud technology product architecture, the WeTrial platform enables full data sharing. “When the product enters the idealized stage, theoretically, any data in the clinical research can be input once and the platform can be shared in real time.” Wang Jinhai said.
In addition, the WeTrial platform can also achieve the same project, cross-regional, organizational task coordination. This kind of task synergy changes the traditional post-reported clinical trial management method into a process-based dynamic management method, so that problems can be discovered in time or even in real time, and solutions and program warnings can be proposed. The WeTrial platform adopts the SaaS service mode and fully supports mobile terminals such as WeChat and APP. Users can select functional modules as needed.
WeTrial Clinical Trial Integrated Cloud Platform
Currently, Sidewin’s WeTrial system has more than 30 corporate clients and assists in managing more than 300 clinical trial projects. At the same time, the company has 80+ clinical trial institutional end customers. “WeTrial is also the first in the clinical trial organization management market and is the only clinical trial organization management system that is fully used from the project to the completion of the whole process.” Wang Jinhai said.
For the future development, Wang Jinhai mentioned: “In the next three years, we will use WeTrial as the starting point, deepen the ability of clinical trial services with innovative drugs as the core, connect pharmaceutical companies and clinical trial centers, and empower clinical research for innovative drugs. “”
In order to achieve more stable development, Sidesheng is also preparing for a new round of financing, and plans to raise 100 million yuan for the continued construction and operation of the WeTrial platform, business development, marketing and recruitment of core talents.